CLASS II ONGOING Drug recall · Reported 22 Dec 2021 · FDA Enforcement Report
Diclofenac Sodium Topical Solution, 5% w/w recalled
Preferred Pharmaceuticals is recalling Diclofenac Sodium Topical Solution, 5% w/w, distributed in Connecticut, Florida, Kansas. The recall was initiated on 29 Nov 2021 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0278-2022
- FDA event ID
- 89143
- Recalling firm
- Preferred Pharmaceuticals, Anaheim, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Nov 2021
- FDA classified
- 13 Dec 2021
- Reported
- 22 Dec 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 29 Nov 2021 | Recall initiated by company | |
| 13 Dec 2021 | Classified by FDA | +14 days |
| 22 Dec 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective container: Out of specification for container integrity leading to bottles leaking.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Diclofenac Sodium Topical Solution, 1.5% w/w, packaged in 150 mL bottles, Rx only, Mfg: SOLA Pharmaceuticals Preferred Pharmaceuticals, Inc., NDC 68788-7707-01
Where it was distributed
Distributed to 5 physician consignees located in the following states: CT, FL, and KS.
Questions about this recall
Is Diclofenac Sodium Topical Solution, 5% w/w recalled?
Yes. Preferred Pharmaceuticals recalled Diclofenac Sodium Topical Solution, 5% w/w on 29 Nov 2021. The recall is Class II and its status is Ongoing. Recall number D-0278-2022.
Why was it recalled?
Defective container: Out of specification for container integrity leading to bottles leaking.
Which lots are affected?
Lot #: E1220B
Where was it sold?
Distributed to 5 physician consignees located in the following states: CT, FL, and KS.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Preferred Pharmaceuticals
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|---|---|---|---|---|---|
| Drug | CLASS II | Artificial Tears Lubricant Eye Drops (glycerin recalledArtificial Tears | Preferred Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Ondansetron ODT Tablets, USP 4mg, unit dose tablets, Mfg recalled | Preferred Pharmaceuticals | Packaging Defects | CA |
| Drug | CLASS II | Clindamycin Hydrochloride Capsules, USP, 300mg recalled | Preferred Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size recalled | Preferred Pharmaceuticals | Potency & Assay | CA, NV |
| Drug | CLASS II | Duloxetine Delayed-Release Cap USP 30mg recalled | Preferred Pharmaceuticals | Nitrosamine Impurity | 5 states |
Other Diclofenac sodium topical recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Diclofenac Sodium Topical Solution 5% w/w, Generic for Pennsaid recalled | Preferred Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Diclofenac Sodium Topical Solution USP, 5% w/w recalled | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Diclofenac Sodium Topical Solution USP, 5% w/w recalled | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Diclofenac Sodium Topical Solution recalled by Direct Rx | Direct Rx | Packaging Defects | Nationwide |
| Drug | CLASS II | Diclofenac Sodium Topical Solution USP, 5 w/w recalled | Teligent Pharma | Foreign Material | Nationwide |